Reliability of 3D Angio QFR Evaluation of Non Culprit Stenoses in STEMI Patients During First Acute Interventional Procedure: Comparison With Staged Procedure FFR
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic performance of TIMI flow based with contrast hyperemia QFR in acute study comparison to FFR in staged procedure reported as positive and negative likelihood ratio in the same lesion
研究概览
简要总结
Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI patients during first acute procedure
详细描述
3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non culprit lesion in staged procedure. Aim of the study is to find a valid correlation between cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for STEMI patients, selecting those,if any, to be treated immediately or in a staged procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI/NSTEMI pts with at least 1 non culprit lesion > 50%
- •Age > 18 years
- •Able to provide signed informed consent
- •Angiographic inclusion criteria:
- •Indication for FFR in at least one stenosis:
- •Diameter stenosis of 50%-90% by visual estimate
- •Reference vessel size > 2 mm in stenotic segment by visual estimate
排除标准
- •Severe asthma or severe chronic obstructive pulmonary disease
- •Severe heart failure (NYHA≥III)
- •S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- •Allergy to contrast media or adenosine
- •Atrial fibrillation
- •Angiographic exclusion criteria:
- •poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete
结局指标
主要结局
Diagnostic performance of TIMI flow based with contrast hyperemia QFR in acute study comparison to FFR in staged procedure reported as positive and negative likelihood ratio in the same lesion
时间窗: 1 - 15 days
Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
次要结局
- Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion(0-15 days)
- Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion(0-1 hour)
研究者
dr. Domenico Di Girolamo
MD
Azienda Ospedaliera Sant'Anna e San Sebastiano